Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)

 描述（由申请人提供）：慢性非瓣膜性房颤（AF）是一种非常常见且成本高昂的公共卫生问题。房颤可能会降低生活质量和持续时间，特别是通过增加破坏性血栓栓塞性中风的风险。抗凝剂，包括维生素K拮抗剂（VKA，例如，华法林）和非VKA抗凝剂（NOAC，例如，达比加群、-xabans）是非常有效的，但未被充分利用的治疗。抗凝治疗使用不足导致临床医生在开具这些药物时面临挑战，患者在生活中使用这些药物时面临挑战。认识到这些挑战，领先的心血管学会于2014年制定了一项关于共享决策（SDM）的I类建议，用于AF高危患者的抗凝治疗个体化。然而，没有经过验证的干预措施支持实施该建议，也没有证据表明SDM对启动和实施抗凝治疗的影响。凭借十多年的经验，我们已经证明了SDM干预措施在其他情况下的实际影响。在此经验的基础上，我们建议使用我们使用以用户为中心的设计开发的SDM工具，ANTICOAGULATION CHOICE，以促进房颤患者及其临床医生之间关于抗凝的SDM。使用随机试验设计，我们计划确定使用该工具对SDM质量、抗凝率和患者依从性的影响。通过产生可靠的基于实践的证据，本试验可以向指南小组提供关于SDM对个体化抗凝治疗质量影响的反馈。我们计划入组999例慢性非瓣膜性AF成人患者，这些患者被认为具有血栓栓塞性卒中的高风险（CHA 2DS 2-VASc评分≥ 1，或女性患者为2），并在学术、社区或安全网诊所接受治疗。我们计划将他们随机分配到护理组，使用或不使用新的SDM工具抗凝选择。试验结果包括SDM的质量（主要终点，目标1）、抗凝率、所选抗凝剂的分布以及12个月时患者对抗凝的依从性（目标2）。如果成功，这项工作将减少抗凝治疗的使用不足，并改善数百万AF患者的护理和结局。

 DESCRIPTION (provided by applicant): Chronic nonvalvular Atrial fibrillation (AF) is a very common and costly public health problem. AF may reduce the quality and duration of life, both, particularly by increasing the risk of devastating thromboembolic strokes. Anticoagulants, including vitamin K antagonists (VKAs, e.g., warfarin) and non-VKA anticoagulants (NOACs, e.g., dabigatran, -xabans), are very effective, but underused treatments. Anticoagulation underuse results form challenges clinicians face in prescribing these drugs and patients face in implementing their use in their lives. Recognizing these challenges, leading cardiovascular societies in 2014 formulated a class I recommendation of shared decision making (SDM) for the individualization of anticoagulation therapy in at-risk patients with AF. However, there are no proven interventions to support the implementation of this recommendation, and no evidence of the effect of SDM on the problem of initiating and implementing anticoagulation. With over a decade of experience, we have demonstrated the practical impact of SDM interventions in other contexts. Building on this experience, we propose to use an SDM tool we developed using user-centered design, ANTICOAGULATION CHOICE, to promote SDM about anticoagulation between patients with AF and their clinicians. Using a randomized trial design, we plan to determine the impact of using this tool on the quality of SDM and on the rate of anticoagulation and patient adherence to this therapy. By generating reliable practice-based evidence, this trial can provide feedback to the guideline panel about the impact of SDM on the quality of individualized anticoagulation care. We propose to enroll 999 adult patients with chronic nonvalvular AF deemed at high risk of thromboembolic strokes (CHA2DS2-VASc score ≥ 1, or 2 in women) and receiving care in academic, community, or safety net clinics. We plan to randomly assign them to care with or without a new SDM tool, ANTICOAGULATION CHOICE. Trial outcomes include the quality of SDM (primary endpoint, aim 1), the rate of anticoagulation, the distribution of anticoagulants chosen, and patient adherence to anticoagulation at 12 months (aim 2). If successful, this work will reduce the underuse of anticoagulation therapy and improve the care and outcomes of millions of patients with AF.